Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland
The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another two weeks.
The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks.
The recommended dose is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks.
15 mg once daily. The dose may be increased up to 30 mg daily as necessary.
When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment, (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.
The recommended dose is 30 mg lansoprazole twice daily for 7 days in combination with one of the following:
H. pylori eradication rates of up to 90%, are obtained when clarithromycin is combined with lansoprazole and amoxicillin or metronidazole.
Six months after successful eradication treatment, the risk of re-infection is low and relapse is therefore unlikely.
Use of a regimen including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been examined. Lower eradication rates were seen using this combination than in regimens involving clarithromycin. It may be suitable for those who are unable to take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low.
30 mg once daily for four weeks. In patients not fully healed the treatment may be continued for another four weeks. For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used.
15 mg once daily. If the treatment fails the dose 30 mg once daily should be used.
The recommended dose is 15 mg or 30 mg daily. Relief of symptoms is obtained rapidly. Individual adjustment of dosage should be considered. If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
The recommended initial dose is 60 mg once daily. The dose should be individually adjusted and the treatment should be continued for as long as necessary. Daily doses of up to 180 mg have been used. If the required daily dose exceeds 120 mg, it should be given in two divided doses.
There is no need for a dose adjustment in patients with impaired renal function.
Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see section 4.4 and 5.2).
Due to reduced clearance of lansoprazole in the elderly an adjustment of dose may be necessary based on individual requirements. A daily dose of 30 mg should not be exceeded in the elderly unless there are compelling clinical indications.
The use of lansoprazole is not recommended in children as clinical data are limited (see also section 5.2). Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.
For optimal effect, lansoprazole capsules should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening.
Lansoprazole should be taken at least 30 minutes before food (see section 5.2). Capsules should be swallowed whole with liquid.
For patients with difficulty swallowing; studies and clinical practice suggest that the capsules may be opened and the granules mixed with a small amount of water, apple/tomato juice or sprinkled onto a small amount of soft food (e.g. yoghurt, apple puree) to ease administration. Capsules may also be opened and granules mixed with 40 ml of apple juice for administration through a nasogastric tube (see section 5.2). After preparing the suspension or mixture, the medicinal product should be administered immediately.
The effects of overdose on lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instruction for treatment cannot be given. However, daily doses of up to 180 mg of lansoprazole orally and up to 90 mg of lansoprazole intravenously have been administered in trials without significant undesirable effects.
Please refer to section 4.8 for possible symptoms of lansoprazole overdose.
In the case of suspected overdose the patient should be monitored. Lansoprazole is not significantly eliminated by haemodialysis. If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.
Shelf life: 3 years.
Do not store above 25°C
Store in the original package in order to protect from moisture.
Al/Al blister.
Pack sizes: 7, 14, 28, 56 and 98 capsules.
Not all pack sizes may be marketed.
No special requirements.
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